CLOSYS- hydrogen peroxide rinse

CloSYS by

Drug Labeling and Warnings

CloSYS by is a Otc medication manufactured, distributed, or labeled by Rowpar Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Hydrogen Peroxide 1.5% (w/v)

Purpose

Oral debriding agent
Oral wound cleanser

Uses

• For temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.
• Assist in the removal of foreign material from minor oral wounds.

Warnings

KEEP OUT OF REACH OF CHILDREN

Do not use this product for more than 7 days unless directed by a dentist, or physician.

When using this product, do not swallow.

Stop use and ask a doctor if

• sore mouth symptoms do not improve within 7 days.
• irritation, pain or redness persists or worsens.
• swelling, rash or fever develops.
  

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older

• Use 10 mL (two teaspoons) around in the mouth over affected areas for at least 1 minute and spit out
• Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician

Children 6 years to under 12 years of age: supervise use

Children under 6 years of age: do not use

Other Information

• Do not use if safety seal is broken or missing
• Cap tightly
• Keep away from direct sunlight
  
• Store at room temperature, 68 to 77°F (20 to 25°C)
  

Inactive ingredients

water, polypropylene glycol, flavors, polysorbate 20, polysorbate 80, sucralose, disodium EDTA, menthol, citric acid

Questions or comments?

call 1-800-643-3337

QUESTIONS

SPL UNCLASSIFIED SECTION

Packaging

A CLEANER MOUTH
A HEALTHIER YOU®

CLoSYS®
Oral Debriding Agent

MOUTH
SORES

SENSITIVE
MOUTH RINSE

PROMOTES HEALING

HELPS CLEANSE & PROMOTE HEALING OF
ORAL SORES, MOUTH BURNS & IRRITATION

For Canker Sores, Cheek Bites,
Irritation from Dentures or Braces,
Gum Irritation

Non Burning, Alcohol-Free
Formula

Gentle Mint

16 fl oz (473mL)

52516-75

Distributed by: Rowpar Pharmaceuticals, Inc., Bridgewater, NJ 08807
1 (800) 643-3337 closys.com

52516-76

INGREDIENTS AND APPEARANCE

CLOSYS 
hydrogen peroxide rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58578-0613
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrogen Peroxide (UNII: BBX060AN9V) (Hydrogen Peroxide - UNII:BBX060AN9V)	Hydrogen Peroxide	1.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)
Polysorbate 20 (UNII: 7T1F30V5YH)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Sucralose (UNII: 96K6UQ3ZD4)
Edetate Disodium (UNII: 7FLD91C86K)
Menthol, Unspecified Form (UNII: L7T10EIP3A)
Citric Acid Monohydrate (UNII: 2968PHW8QP)

Product Characteristics
Color		Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58578-0613-1	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/27/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	01/27/2025

Labeler - Rowpar Pharmaceuticals, Inc. (783704661)